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In Vitro Diagnostic Solutions: Changing the Diagnostic Development Paradigm

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Robert Harper, President & CEO

Glucose-6-phosphate dehydrogenase deficiency(G6PD) is a chronic metabolic disorder that affects 400 million patients globally and has no cure. Patients who suffer the most are neonates with G6PD deficiency, or those are exposed to certain foods, infections, or medications like anti-malarials. These exposures can trigger a premature breakdown of the red blood cells, resulting in life-threatening hemolytic anemia. That said, at-risk patients require early screening and monitoring for G6PD on a regular basis. Currently, there are no efficient or accurate methods to do this, especially in regions of the world that need it most, like regions of high malaria incidence. “The emergence of new treatment regimens to aid in the eradication and prevention of malaria has created a critical need for the quantitative point-of-care test (POCT) for the diagnosis of G6PD deficiency. However, currently no newborn screening programs are available for this diagnosis,” reveals Robert Harper, President, and CEO of In Vitro Diagnostic Solutions (IVDS), an organization that develops novel testing technologies for the healthcare, veterinary, and consumer markets.

With support from the National Institute of Health (NIH) and National Science Foundation, IVDS’ mission is to develop point-of-care assays for the detection and monitoring of rare metabolic disorders. The company draws from more than 25 years of experience in product development, solid-phase chemistry and specialization in the development and commercialization of point-of-care diagnostic solutions to develop advanced diagnostic solutions and products. Governed by the mission of providing cost-effective results in the development of point-of-care diagnostics, IVDS maintains strong relationships with community health experts. In the case of the G6PD community, this includes over 50 experts in organizations like WHO, PATH—an NGO that evaluates new diagnostic tools—and governments of lesser developed and malaria-endemic countries. “In underdeveloped markets like Southeast Asia, people are facing several issues regarding standard newborn screening and limited access to care and technology. Beyond our development efforts, we are looking for ways to disseminate our G6PD product to the primary and secondary healthcare system,” says Harper.

IVDS is also developing point-of-care diagnostics for Phenylketonuria (PKU), a common inherited metabolic disorder affecting 1 in 8,000 people globally, mostly newborns in developing countries. There are currently no means of home monitoring the Phe levels in the patients, which can exacerbate their condition without proper control. Worse yet, there are no newborn screening programs in 2/3 of the world. With a resolve to improve this scenario, IVDS is developing a home monitoring device and new born diagnostics device that will benefit patients by providing a real-time understanding of their condition and helping them manage it proactively.

IVDS’ initiatives for PKU diagnosis were honored with a Phase I award from the National Institute of Child Health and Human Development (NICHD). IVDS is working in close partnership with several organizations, including the National PKU Alliance.

For us, it’s not just about the knowledge and experience the scientific team has gained over the last decades; it is a process of understanding our customers, both patients and industry partners, in order to commercialize the science to help patients, and get our products into their hands

Another major focus of IVDS is improving the standard of care for testing bilirubin, which helps inform patients of their overall liver function and hemolysis with levels of anemia, critical for severe conditions such as neonatal jaundice which affects an estimated 50 percent of term and 80 percent of preterm infants. Current technologies typically require blood sample collection with needle for adults or heel prick for children. The IVDS bilirubin test will allow healthcare providers to monitor these levels much more efficiently with a smaller blood sample, and obtain faster results. Again, IVDS was honored to receive a Phase I award for the development of a Bilirubin point-of-care quantitative diagnostic tool. IVDS is currently completing the Phase I development effort and plans to submit a Phase II application early in 2020.

With a dynamic team of experienced scientists on board, IVDS is well-positioned to provide consulting services for creating portable and affordable point-of-care devices. The team specializes in dry chemistry development, microfluidic design, protein and enzyme stabilization, in-situ blood separation, and control development. “Colorimetric, solid-phase chemistry is somewhat of a skilled art and science, requiring years of experience to understand the combinations of active incipients and stabilizing excipients to provide an accurate test. Besides our in-depth knowledge of solid-phase chemistry, we bring in rich experience in in-situ blood separation, which sets us apart from other players in the market whose tests require serum or plasma,” notes Harper.

By sharing capabilities, IVDS hopes to build strategic relationships with industry partners to license and manufacture their technologies, as well as help the partners develop new technologies. “En route to creating the next generation of healthcare, veterinary, and consumer products, our strategy is to elevate and highlight awareness of unmet needs and disease burdens of people suffering from rare metabolic disorders. In order to maintain close relationships with the scientific and patient community, we participate in numerous industry conferences, conduct workshops, are in constant communication through emails and newsletters, and invest in innovative products for improving patient lives,” explains Harper. “For us, it’s not just about the knowledge and experience the scientific team has gained over the last decades; it is a process of understanding our customers, both patients and industry partners, in order to commercialize the science to help patients, and get our products into their hands.” With an aim to continue their innovation streak, IVDS looks forward to partnering with large medicine and medical food companies to increase the reach of its products and benefit patients. Since its inception, IVDS has received over $2 million in non-diluted funding.

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